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Glossary
This list contains a glossary of commonly used words, phrases and abbreviations which may be particularly useful to those new to the Agency. The list is compiled by the Library team, please contact Information Services to suggest amendments.
Term Definition
A-D
ABHI
Association of British Healthcare Industries.This is the trade association
representing medical device technology manufacturers and distributors in
the UK
ABPI
Association of the British Pharmaceutical Industry. This is the trade
association representing the manufacturers of prescription only medicines
in the UK
Abridged application
An application for a marketing authorisation in which the applicant is not
required to provide full results of tests and trials because the product is
essentially similar to one already licensed in the UK (or the constituents of
the product have a well established medicinal use)
ADR
Adverse Drug Reaction. A harmful and unintended reaction that occurs at
a dose normally used for the prophylaxis, diagnosis or treatment of
disease or the modification of physiological function
ADROIT Obsolete term. Replaced by the Sentinel PV Case Folder
AEGIS Obsolete term. Replaced by secure internet portal
AFSAPPS The French Medicines Regulator
AGES Austrian Agency for Health and Food Safety
AI
Adverse incident. This is an event that produces, or has the potential to
produce, unwanted effects involving the safety of patients, users or other
persons
AIMDD Active Implantable Medical Devices Directive
mailto:[email protected]
AITS
Adverse Incident Tracking System. This is the the MHRA internal database
for processing and monitoring medical adverse incident reports from health
professionals and members of the public
AM Agency Memorandum. An official notice about MHRA developments
API ctive Pharmaceutical Ingredient
AR Assessment Report
ARM Application to reclassify a medicine. A consultative letter issued when an
application is made for a change in legal status of a product
ASMF
Active Substance Manufacturer. A Marketing Authorisation Holder will
often purchase the active from an external supplier and the MHRA will
refer to their drug master file
ASPRs Anonymised Single Patient Reports. [Formerly ASPPs: Anonymised Single
Patient Print Outs]
ATC Anatomical, Therapeutic, Chemical. This is a World Health Organisation
classification of drug substances
AT Assistive Technology. This is any device or technology that assists a
disabled person. Formerly: P&CC
AXREM Association of X-ray Equipment Manufacturers
BAN
British Approved Names. This is a list of officially recognised names of
medicinal substances produced by the British Pharmacopoeia
Commission.
BARQA British Association of Research Quality Assurance
BCPNN Bayesian Confidence Propagation Neural Network used for drug safety
signal detection
BCGA British Compressed Gases Association
BAV British Avenue, Blackpool (Centre for Assistive Technology).
BEMA Benchmarking of European Medicines Agencies
BfArM German Federal Institute for Drugs and Medical Devices
BGMA
British Generic Manufacturers Association represents the interests of UK
based manufacturers and suppliers of generic medicines and promotes
development of generic medicine industry.
BHMA
British Herbal Medicines Association represents the interests of herbal
medicine in the United Kingdom and ensures its continued statutory
recognition.
Biological medicinal
products
Biological products
Biopharmaceutical
products
A biological medicinal product contains an active biological substance. The
following are considered as biological medicinal products: recombinant
proteins, monoclonal antibodies, blood products and immunological
products such as sera and vaccines, allergens and advanced technology
products such as gene and cell therapy products.
Biologicals Products which cannot be tested adequately by chemical means such as
vaccines.
Biosimilar
The active substance of a biosimilar medicine is comparable to a biological
reference medicine. Biosimilar and biological reference medicines are
used at the same dose to treat the same disease. The name, appearance
and packaging of a biosimilar medicine differs to that of a biological
reference medicine.
Biotechnology
A biotechnology product is one manufactured by recombinant DNA
technology, one where genetic manipulation of cells is required, or a
monoclonal antibody. Applications for these products are required to be
submitted through the European Centralised procedure.
BIR
British Institute of Radiology. The BIR is unique in the UK as a
multidisciplinary radiological organisation which welcomes all radiological
professionals into its membership. Equal medical/non-medical
representation is maintained on its Council. Multidisciplinary collaboration
and networking is fostered in particular through its scientific committees
and scientific meetings.
BMA British Medical Association
BNF
British National Formulary. This is a list of medicines used in the UK
compiled by the British Medical Association and the Royal Pharmaceutical
Society.
Borderline products
Products which are close to the boundary between medicines which need
a licence, and products such as nutritional supplements, cosmetics etc.
which do not. Classification depends either on the ingredient or the claim
or both
BP
British Pharmacopoeia. This is the only comprehensive collection of
standards for UK medicinal substances. It is an essential reference for all
individuals and organisations involved in pharmaceutical research,
development, manufacture and testing.
BPC
British Pharmacopoeia Commission. is responsible for preparing new
editions of the British Pharmacopoeia and for selecting and devising British
Approved Names (BANs).
BROMI Better Regulation of Over the Counter Medicines Initiative.
BSE Bovine Spongiform Encephalopathy
BSI British Standards Institution
CA
Competent Authority. This is a body which has the authority to act on
behalf of the government of an EU Member State to ensure that the
requirements of the Directives are carried out in that MemberState
CAP
Centrally authorised product. In the European Union (EU), a company
may submit a single application to the European Medicines Agency (EMA)
for a marketing authorisation (licence) that is valid simultaneously in all EU
Member States, plus Iceland, Liechtenstein and Norway. This is
mandatory for certain types of medicines and optional for others
CAS
Current Awareness Service. This is a service provided by the Library
services of the Information Centre designed to help you stay informed of
relevant research, news and issues for your business area. The main parts
of the service include selective dissemination of articles from scientific
journals; the provision of electronic table of contents alerts for new issues
of journals and the circulation of print journals
Case
The Sentinel application suite includes a case-based system, in which
requests are progressed and tracked as individual cases. A case (or
casefolder) is a single unit of work. Different types of cases represent
different types of submissions in the lifecycle. Generally speaking there is
an initial case which following approval can result in further submissions
for amendments or changes (referred to as variations in the Product
Licence Case Folder).
Case attributes
The case attributes page within a casefolder that contains high level
information about the case. For example, for a Product Licence case this is
where information can be found about the submission type, type of
procedure and worktype. Other information includes: Product Name,
Active Substances, etc
CAPLA/CANDA
Computer Assisted Product Licence Application/ Computer Assisted New
Drug Application. This is a means of submitting product licence
applications by computer
CBER (FDA) Centre for Biologics Evaluation & Research
CCDS
Core company data sheet is a company-internal global reference labelling
document used to direct the content of local (affiliate) labelling. The CCDS
may also be used as an attachment to a Periodic Safety Update Report
(PSUR), in this context, all the safety information in a CCDS, or a
specifically identified (e.g by bold print) subset of this safety information,
serves as reference information for determining listedness
CD A controlled drug
CDF Competence Development Framework
Centralised
application
This is part of the EU licensing system resulting in a single European MA
and direct access to a single community market. The Rapporteur/ Co-
rapporteur are responsible for the pre-authorisation assessment and the
Rapporteur continues with post-authorisation evaluation and
pharmacovigilance via the EMA. Refer to the EudraPharm database on the
EMAs website for